IMPROVING ACCESS TO DIGITALTHERAPEUTICS IN EUROPE
June 2023

www.efpia.eu

02

SUMMARY
Digital therapeutics (DTx) deliver evidence-based therapeutic interventions
to patients that are driven by software programmes to prevent, manage,
alleviate or treat a medical disorder or disease. They are used to optimize
patient care and health outcomes. Given the rising importance of DTx
for patients, health systems, and the industry, as well as the challenges
they face with existing access pathways, the pharmaceutical industry
considers it timely to set out how DTx should be defined, their benefits,
the barriers to their use, and associated policy areas needing attention.
Currently, the use of DTx in Europe is limited, with progress in integrating DTx into access and carepathways only in a small number of countries. As a result, DTx face unpredictable requirements or
standards for much of the development and commercialisation pathway, including authorisation, value
assessment, reimbursement, and pricing. Specifically, there are four key challenges:
A lthough DTx are governed by EU Medical Device Regulations, there is a lack of harmonization in regulatory
requirements due to differences in interpretation
 T here are challenges in the harmonisation of evidence requirements and lack of value assessment processes T here is no standardised or specific reimbursement pathway for DTx in most countries
 T here is inadequate funding, and DTx reimbursement pathways do not ensure uptake
While EFPIA welcomes the initiatives already made in promoting access to DTx in some countries, there is aclear opportunity for both policy change within the individual Member States and for harmonisation across the
EU. To that end, EFPIA recommends the following actions to be considered at the national and European levelto improve access to DTx:
H armonized regulatory requirements with clear guidance are required to ensure streamlined accessV alue assessment requirements need to be tailored and fit-for-purpose for DTx and more predictable andconsistent, and involve a portfolio of evidence that can include real-world evidenceM ember States and the European Commission should consider supporting collaboration between countries
to enable harmonisation of clinical evidence requirements
 E uropean Commission and Member State collaboration will be needed to support data sharing and build
infrastructure to realise the potential of data generated by DTx
M ember States should create clear and transparent national pathways for DTx pricing and reimbursement
 P ayers should permit flexible approaches allowing provisional access while additional data is generated
 P ayers should be willing to implement novel payment models to manage evidence uncertainties
 T o ensure that DTx are adequately funded, funding needs to be explicit and budgeted, and should not havea financial burden on patients
 Increasing DTx uptake will require collaborative efforts between policymakers, HCPs, and companies.
To develop trust in DTx, stakeholders must be prepared to work together to enhance the education andexperience of HCPs and patients.

Contents
Introduction

04

The use of DTx today

07

Barriers to DTx across the market access pathway

09

Policy recommendations

14

References

17

INTRODUCTION
Interest in the potential for digital therapeutics (DTx) to transformthe treatment of patients has intensified over the last few years,
particularly in the wake of the COVID-19 pandemic and as thepotential of digital health tools has increased due to advances in
artificial intelligence and related technologies. Although overall
health digitalisation remains low, many healthcare systems haveshown increased interest in the digitalisation of health processes,organisations, and delivery, and have incorporated digital healthinto pandemic and recovery policy.
Given the rising importance of DTx for patients, health systems,
and the industry, as well as the challenges posed by existing
access pathways for these products, the pharmaceutical industry
considers it timely to set out how DTx should be defined, thebenefits they offer, the barriers to their use, and associated policy
areas needing attention.
A DEFINITION OF DIGITAL THERAPEUTICS
DTx are a subset of the broad area of digital health.
Digital health includes health apps, telehealth andtelemedicine, and a wide range of health information
technologies used by healthcare systems andproviders. Digital medicines are a subset of digital
health, and DTx are in turn a subset of digital
medicine.* DTx deliver evidence-based therapeuticinterventions to patients that are driven by software
programmes to prevent, manage, alleviate, or treat
a medical disorder or disease. They can be used
independently or in combination with medications,devices, or other therapies to optimise patient careand health outcomes, and their aim to is achieve
positive clinical outcomes and / or deliver patientrelevant improvements in the process and structureof healthcare systems. Under this definition, DTx
are classified as medical devices according to
the Medical Device Regulation 2017/745. The
definition of DTx includes interventions whichhave an associated hardware component, as longas the software is the driving component of thetherapeutic effect. 1 The distinction between DTx
and digital health is illustrated in Figure 1.
There are three main types of DTx: standalone DTx,
which operate independently of any other medical
product such as a pharmaceutical; companion DTx(disease-specific), which are used in concert withmedications, devices, or other therapies to optimise
patient care and health outcomes, with a single DTx
having potential applications as a companion todifferent therapies; and combination DTx (productspecific), which comprise software and one or moreother components (drug-software, device-software,drug-device-software) intended for use only in
conjunction with each other.2† DTx encompass awide range of therapeutic areas and are based on
several digital health tools, including apps, web-based
interventions, videogames, and virtual reality, including
where these digital tools interact with hardware
components such as wearable measurement devices.3

Digital health includes technologies, platforms, and systems that engage consumers for lifestyle, wellness, and health-related
purposes; capture, store or transmit health data; and/or support life science & clinical operations. Digital medicine includes
evidence-based software and/or hardware products used for monitoring/measurement of human health†This is in line with EU MDR in delineating drug-device combinations “placed on the market in such a way that they form a single
integral product which is intended exclusively for use in the given combination”*05

FIGURE 1: Definition and types of digital therapeutics

Source: CRA drawing on Deloitte report on Digital Therapeutics (2021)

BENEFICIARIES OF DTx INCLUDE PATIENTS,
CLINICIANS, AND HEALTHCARE SYSTEMS
DTx deliver benefits to patients, clinicians, healthcare
systems, payers, regulators, and other bodies thatgovern patient access to innovative therapies.
The most direct beneficiaries of DTx are patientsthemselves. DTx can empower patients by improving
their experience and outcomes, the coordination of theircare, and their engagement with healthcare providers.5
Furthermore, DTx can mitigate treatment side effects.
The potential applications of DTx have already become
very broad. Many focus on delivering behaviouralchanges through cognitive behavioural therapy (CBT).
For example, there are DTx used to treat patients withdepression and depressive moods by delivering CBT,6and apps aimed at treating insomnia that are effective
for patients as an alternative to sleeping pills.7 Other
examples demonstrate the varied uses of DTx such as in
the self-management of diabetes;8 digital interventions
for cancer patients found to increase overall survival;9and those supporting remote rehabilitative carefollowing hip and knee and weight-loss surgery.10 ManyDTx allow patients to be treated at home and to be
more directly in control of their care, which can increase
patient engagement and participation. For example, aninteractive app enabling self-management for cancer
patients was found to promote patient participationin their care.11 There is also potential for more holistic
patient management with tailored approaches basedon the individual patient’s needs.

The potential benefits of DTx extend beyond patientsto include stakeholders throughout the healthcare
system. For clinicians, DTx offer alternative or improved
therapeutic options, improving overall monitoring oftreatment and information on care and patient response.
DTx often enable data sharing between patients andhealthcare professionals (HCPs). For example, there aretools for managing epilepsy which collect data thatcan be shared directly with clinicians.12 In particular,
DTx can provide continuous exchange of information
with clinicians, compared to the fragmentary level of
information gathered during personal interactions
between patients and HCPs.
For healthcare systems, DTx could be used to target
unmet needs or underserved areas in healthcare byleveraging the unique characteristics and benefits
they can deliver to patients. For example, DTx may
be launched in indications with limited or inadequate
treatment options, thereby addressing the unmet need
and alleviating healthcare system pressures. One digital
therapeutic used in lung cancer patients decreased
the use of imagining procedures by 49% per patient
per year compared to the standard of care,13 and wasfound to be cost-effective in reducing follow-up costs
compared to conventional monitoring.14 DTx havesignificant potential to reduce the overall burden on
healthcare systems, such as by preventing hospital
visits by improving self-management or providing
therapy remotely. For example, a DTx that delivers
neurobehavioral therapy for opioid use disorder

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was found to be associated with fewer inpatient,emergency department, and other clinical encounters,
increased case management/rehabilitative services,and lower net costs over six months.15 Healthcare
systems would similarly benefit from DTx valuablefor prevention, potentially addressing public healthneeds. For example, there are diabetes-focused DTx
that help patients modify behaviours and eating
habits through CBT.16 There may also be a potential tointegrate the data generated into healthcare systems
more broadly, improving patient care and allocationof resources at the macro-level. DTx enable data to becollected, processed, and analysed, and then tailored
to an individual’s medical needs. There is also a newopportunity for regulators and payers to integrate data
into decision-making, such as the collection of realworld evidence (RWE), to support the implementationof value-based healthcare.

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THE USE OF DTx TODAY
Despite the extent of their potential benefits, the useof DTx in Europe is still limited. In only a handful ofMember States there has been progress in integrating
DTx into market access and care pathways. These
existing approaches are summarised in Table 1.
Germany was the forerunner in terms of improving
market access pathways for DTx in its implementationof the Digital Healthcare Act (Digitale Versorgung
Gesetz, DVG) in 2019.17 The Act established a “FastTrack” process for qualifying apps (“DiGA”) that leads

to inclusion in a central directory of digital healthapplications, for which reimbursement becomes
available, although this is currently limited tostandalone DTx with low to medium (MDR Class I andIIa) risk.18 As of January 2023, 161 applications were
submitted to the DiGA for review – 125 for provisional
listing and 36 for final listing. Of these applications,
the BfArM has made 40 positive decisions for either
provisional or final listing.19

TABLE 1: Existing approaches to DTx market access in selected markets*

Country

Belgium

Germany

National value
assessment
framework

National
reimbursement
pathway

Available funding
mechanisms







DTx clinical and/or
socioeconomic value
evaluated throughValidation PyramidApps in Level M3 ofValidation Pyramid
reimbursed by payers

DiGA process:Standalone DTx evaluatedby BfArMDiGA process:All listed DiGA are
reimbursedCentralised funding
for mHealth apps


GKV-SV centralised
funding for DiGA

Apps in Level M3 ofValidation Pyramid
reimbursed by payers

Centralised funding
for mHealth apps











France†

Italy

Netherlands
Covered by individual
health insurers*In order to develop this white paper a landscape assessment of policies around digital therapeutics was conducted for these 8 European
markets†In addition to the existing medical device pathway, France is introducing a pathway for fast access for reimbursement of telemonitoring
activities and digital medical devices with therapeutic aim. As of January 2023, implementation decrees are still to be published.

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







Spain


Evidence of limited
regional reimbursement

Sweden
UK

NICE has developed
evidence standards
framework for digital
health technologies

Belgium provides a second notable case where a
distinct access pathway for DTx has been implemented.
The mHealthBelgium platform collects all apps thathave received a CE mark as medical devices andassesses them through the “validation pyramid” into
three levels.20 Only mHealth apps that show “socialeconomic evidence” and reach Level 3 of the pyramid
can be reimbursed. However, progress in utilising the
pyramid to improve access for patients has been very
gradual: although the pyramid was created in 2018and Level 3 rolled out in 2021, only one app hasreached Level 3, which is currently only categorised as
Level 3 light, providing temporary reimbursement (asof January 2023).21
The other notable example is the United Kingdom.
In England, there has been progress in establishinga value assessment framework for DTx, althoughwider access pathways are less developed than inGermany or Belgium. Specifically, DTx are classified by
the National Institute for Health and Care Excellence(NICE) based on their functions and then stratified
into evidence tiers based on the potential risk to theuser.22 The shortcoming of the UK’s current progressis that there is no funding mandate for digital healthtechnologies that are recommended by NICE, incontrast to pharmaceuticals, 23 although NICE aremaking conditional recommendations for digital
cognitive behaviour therapies as part of an Early Value
Assessment pilot.



Can be funded
locally by Integrated
Care Systems

For the other countries assessed in the development of
this paper (Table 1), there is a lack of specific national
pathways or frameworks for DTx. However, in somecountries access has been possible under existing
frameworks, especially through the medical devices
route. In France, for example, the common pathways
for medical devices also enable DTx evaluation andpricing, with specific guidelines and requirementsthat have been published,24 and in the Netherlands,
there has been reimbursement of health apps byindividual health insurance companies. 25 In 2022
France introduced additional pathways on top of thealready existing medical devices route, specifically,a standard pathway for telemonitoring activities (nonDTx) and a fast access for temporary reimbursementof telemonitoring activities and digital medical devices
with a therapeutic aim, which includes DTx.26

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BARRIERS TO DTx ACROSS THE
MARKET ACCESS PATHWAY
Several barriers are hindering the adoption of DTx, and there are no specificmarket access pathways for these technologies in most markets. As a result,DTx face the challenge of unpredictable requirements or standards for muchof the development and commercialisation pathway, including authorisation,
value assessment, reimbursement, and pricing.28 Specifically, there are four
major challenges impeding access to digital therapeutics: LACK OF HARMONIZATION IN REGULATORY REQUIREMENTS ACROSS EU MEMBER STATESDUE TO DIFFERENCES IN INTERPRETATION. DTx are subject to the European Regulation on
Medical Devices 2017/745 (MDR) and are regulated by National Competent Authorities. Although
the CE mark by a notified body is recognised across Europe, interpretation of the dossierrequirements can vary between Member States as DTx products are novel and innovative, andexpertise is still building.
 CHALLENGES IN EVIDENCE REQUIREMENTS AND LACK OF PROCESSES FOR DTx VALUEASSESSMENT. Due to lack of specific frameworks, it is unclear what evidence DTx requires for
positive value assessments. There is a concern that payers will expect all DTx to be supported withevidence from randomised controlled trials (RCTs), which are not always the best approach for
DTx evidence generation. This also exacerbates the problem that evidence requirements are notharmonised between countries, leading to difficulties for companies to develop their clinical plans.
 THERE IS NO STANDARDISED REIMBURSEMENT PATHWAY FOR DTx IN MOST COUNTRIES.
This means that DTx may not be reimbursed, be subject to long delays, or be reimbursed byindividual providers, resulting in uncertainty over requirements for reimbursement.
 DTx DO NOT RECEIVE ADEQUATE FUNDING, AND DISTINCT REIMBURSEMENT PATHWAYSDO NOT GUARANTEE DTx UPTAKE IN PRACTICE. Few countries provide funding so that DTx
can be made available to patients. However, even with adequate funding, there are further uptake
challenges due to a lack of readiness from physicians and patients to use them. For example,
patients and HCPs are insufficiently educated in the potential of digital technologies. Given
that they are a new approach to treatment, HCPs and patients will need more education andexperience to better understand the potential of DTx and to secure trust in their value and quality.
Several of the key barriers are not unique to DTx and reflect current or previous challenges in otherareas of healthcare such as medicines and medical devices. Progress in those areas in clarifying
requirements and improving harmonisation is much more developed than for DTx, and so it is
crucial that this progress is learnt from.

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L ACK OF HARMONIZATION IN
REGULATORY REQUIREMENTS
ACROSS EU MEMBER STATESDUE TO DIFFERENCES IN
INTERPRETATION
Given the definition of DTx set out above, DTx will
be considered medical devices and consequently aregoverned by the European Regulation on Medical
Devices 2017/745 (MDR). DTx are considered
Medical Device Software. For DTx to be evaluatedor reimbursed by national payers, a conformity
assessment is conducted, and a CE Mark is granted
by a designated regulatory authorized Notified Body.‡
As with all software, medical device software has
fast cycles of innovation and development that can
result in many version upgrades to the software inquick secession. Medical device legal frameworks andrelated authorities were not necessarily developedwith novel and swift-moving software changes
in mind. Improvements to the existing regulatory
pathway that would allow a flexible risk-based
approach to regulation would foster innovation andminimize risks to patients by not inhibiting the paceof changes while maintaining high safety, efficacy andquality standards.
The EU MDR came into force in 2021, replacing
the existing Medical Devices Directive and Active
Implantable Medical Devices Directive. As per theEuropean Commission’s Medical Device Coordination
Group (MDCG), Medical Device Software (MDSW) is
categorised into four classes based on inherent risks
associated with the intended use – Class I (low risk),Class IIa (medium risk), Class IIb (medium/high risk)
and Class III (high risk).29 At the moment, as there arefew DTx products that have undergone a conformity
assessment, there is little regulatory precedent indetermining the appropriate risk classification. It
is anticipated that as regulatory agencies and DTx
developers continue to learn and gain experience on
the risk posed to patients, more precedent will beestablished. As a general matter, DTx products arehighly innovative and novel in nature, and so it willbe essential that notified bodies continue to prioritize
obtaining the necessary expertise and knowledge tobe able to effectively evaluate these products. Thereis concern that a lack of capacity within the notified
bodies will negatively impact the scientific advice andreview processes.

‡

In addition to the MDR, as DTx products are medical
devices, they must also comply with data protection
requirements, as they relate to the General Data
Protection Regulation (EU GDPR). However, in addition
to EU GDPR, several Member States have additional
regulatory requirements related to security andprivacy. For example, Germany has implemented dataprotection laws that go beyond GDPR requirements,
and the UK’s National Health Service (NHS) launched
its Digital Technology Assessment Criteria (DTAC)
including criteria around safety, data protection,technical assurance, interoperability, and usability.30,31
A lack of harmonization across Member States inthese areas poses an additional challenge for DTx
developers.

CHALLENGES IN EVIDENCEREQUIREMENTS AND LACK OFVALUE ASSESSMENT PROCESSESFOR DTx
DTx need to deliver health benefits and value formoney.32,33 This is the primary rationale for healthtechnology assessment (HTA) of pharmaceuticals,
which are used to inform decision-making, particularly
on reimbursement, as to the value of new healthtechnologies. However, a key challenge for DTx isthat there is no standardised framework for value
assessment, meaning that the evidence requirementsa developer needs are uncertain and are likely to vary
between markets.
This is particularly problematic for DTx due to thedifferent types of evidence that are expected tobe relevant in demonstrating their value. Whilerandomised controlled trials have already been usedfor DTx, real-world evidence (RWE) is expected to playa role in the evaluation of DTx.34 This is because RCTs
may not always be the most appropriate approachfor evidence generation given that DTx require
new methods that allow continuous assessmentof effectiveness in real-world settings, especially assoftware updates result in regular changes to thetechnology.35 DTx also have unique capabilities formeasuring patient-level data to support this. A related
issue is that current HTA frameworks assess products
within specific indications with a separate evidence
package and trials per indication. Many DTx, bycontrast, take a more patient-holistic approach, suchas by supporting patients with several conditions. A

Combination DTx will go through the EMA regulatory pathway for pharmaceuticals, but the DTx component will still requirea CE mark.

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switch from indication-based HTA to a more patientholistic approach to value assessment (including
acceptance of evidence supporting a patient-holisticview) is equally important.
The lack of a value assessment process for DTx
is likely to delay their uptake. Firstly, developing
value assessment practices is necessary for payers
to be willing to reimburse DTx. In addition, value
assessment can contribute to building HCP trust in
DTx. Currently, only Belgium, Germany, and Englandhave developed a value assessment process for DTx,
which are summarised in Figure 2.§ To date, thesevalue assessment processes have been commissioned
and conducted at the national level, and therequirements for clinical evidence that DTx developers
need to submit for value assessment vary between
the Member States. So far, national evaluations havebeen based on clinical trials in a given country without
mutual recognition of evidence between countries. For
example, in Germany, the BfArM require local clinicalstudies (or transferability to the German healthcare
situation if conducted outside Germany).36 The industry
has therefore faced the difficulty of designing studies

and the increasing cost of developing local evidence.
There have also been challenges around national
capacity for DTx value assessment: despite the growing
number of DTx that have been approved, only a small
number have been successfully assessed as eligible forreimbursement.

Impact of EU HTA regulation on DTx
In the long term, the value assessment of DTx will be
impacted by the implementation of EU HTA for medical
devices. In January 2022, the EU’s Health Technology
Assessment Regulation (2021/2282) entered into force
and will apply from January 2025.38 Starting in 2025,
Joint Clinical Assessment (JCA) will include oncology
therapies, advanced therapy medicinal products(ATMPs), and selected medical devices, with the scopeof products to be expanded thereafter.39 The use of EU
HTA for DTx will depend on three factors: their type,that is, whether they are a standalone, companion, or
combination product; their medical device risk class;and whether they are selected for JCA, if eligible.**These factors are summarised in Figure 3. The numberof DTx that undergo JCA is expected to be limited.

FIGURE 2: European countries with value assessment frameworks for DTx37

As noted above, France is implementing an early access reimbursement programme that includes DMTs with a therapeutic
purpose, which will require CNEDiMTS to consider the DMT innovative, however implementation decrees are yet to be published(as of January 2023)

§

** T
 he criteria for selection as one or more of: unmet medical needs; first in class; potential impact on patients, public healthor healthcare systems; incorporation of software using artificial intelligence, machine learning technologies or algorithms;
significant cross-border dimension; major Union-wide added valueTHERE IS NO STANDARDISEDREIMBURSEMENT PATHWAY FOR
DTx IN MOST COUNTRIESGiven their clinical benefits and the potential toapply methodical value assessment processes tothem, DTx, which have been positively evaluated,should be reimbursed by health systems. However,
the requirements for reimbursement are unclear in
most countries, and there is no standardised accesspathway. As a result, the time taken for reimbursement
decisions is too long. In some countries, this meansthat there is unlikely to be any reimbursement of DTx,
while in others, individual providers have been willing
to reimburse DTx – such as in the Netherlands – but
resulting in uncertainty over the requirements due tothis decentralised approach.
Therefore, a key challenge for DTx is ensuring that
there is a mechanism to enable their reimbursement.
Removing barriers to reimbursement is a key step
to ensuring the widespread adoption of DTx, andrecent activity in some Member States demonstrates
that progress is being made in this direction.

F or ex ampl e, i n September 2020, G erman yannounced that it would allow the reimbursementof prescription digital health applications (Digitale
Gesundheitsanwendungen, DiGA). Germany’s DiGA
process provides a clear pricing and reimbursement
pathway for standalone DTx, which has been
essential in enabling patient access to DTx. As noted
above, reimbursement pathways also exist or are
being implemented in Belgium and France.40,41
In addition to the overall pathway for the pricing
and reimbursement of DTx, some Member States
have included additional principles in their pricing
and reimbursement frameworks. For example, theGerman and Belgian reimbursement processes allow
for provisional access for DTx to finance additional
evidence generation (although it is unclear whether
payers will still expect confirmative randomized
controlled trials, as is the case with pharmaceuticals).
The Belgian validation pyramid has demonstrated thisprinciple by splitting Level M3 of the pyramid into M3(“M3 light”) and M3+. M3- apps are able to receive
provisional access during data collection.42

FIGURE 3: Determining eligibility and selection of DTx for EU Joint Clinical Assessment Tx DO NOT RECEIVE ADEQUATEDFUNDING, AND DISTINCTREIMBURSEMENT PATHWAYSDO NOT GUARANTEE DTx UPTAKEIN PRACTICE
As with pricing and reimbursement, policy for thefunding and uptake of DTx will be determinedat the national level. In fact, there are alreadyconsiderable differences in how DTx are funded
between countries, reflecting differences in howhealth systems are structured. For example, inGermany DiGAs are prescribed at the expense ofstatutory health insurance (SHI) if listed in the DiGA
directory, while in France, DTx will have to be listedon the LPPR list (medical device budget) or can receive
experimental coverage for innovative products (Article
5143 and Forfait Innovation44). In Belgium, DTx will be
paid as part of the healthcare service from hospitalbudgets or budgets available from certain healthcare
services (DRGs). Although these differences are to be
expected, given variations in how healthcare budgets
are organised between countries, there is nonethelessa common requirement to ensure that DTx are
adequately funded. Currently, funding for DTx within
the EU has been highlighted as a major challenge,
with only a few countries making DTx available topatients. In fact, improving funding for DTx at theMember State level may simplify the market accesspathways for new digital health products.

Even if DTx are adequately funded, their uptake is
not guaranteed. This will depend on the readiness of
HCPs to prescribe them, which may be an obstacle
to their use, given low awareness and recognitionof the potential value of DTx and a lack of attempts
to educate physicians. Although the acceptance ofDTx is improving, the current evidence suggests that
HCPs are reluctant to prescribe DTx: a study from
Germany found that within the first 12 months
after DiGA’s implementation, only 14% of eligible
HCPs had prescribed at least one DiGA, which wereheavily concentrated in three medical specialities.
The education and training of physicians are likely torequire collaborative initiatives involving policymakers,
professional organisations, and the DTx developers
themselves.
There are also challenges around healthcare
infrastructure, which may delay the adoption of DTx
and the realisation of their potential benefits. Although
the utilisation of data generated is expected to be abenefit of broader access to DTx, many countries haveunderdeveloped basic digital health infrastructure,such as issues around the implementation of electronic
health records. As such, there are difficulties aroundintegrating DTx data into healthcare infrastructureso that their use can be scaled up rapidly and theirpotential benefits in terms of data generation can becapitalised on.46

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POLICY RECOMMENDATIONS
Despite their potential benefits, most countries have taken limited action toaddress the significant challenges in existing access pathways. While EFPIA
welcomes the initiatives already made in promoting access to DTx in somecountries, there is a clear opportunity for policy change across the EU, bothwithin the individual Member States and with regards to harmonisation acrossall Member States. To that end, EFPIA recommends the following actions to beconsidered at the national and European level to improve access to DTx:

HARMONIZED REGULATORY REQUIREMENTS WITH CLEAR GUIDANCEARE REQUIRED TO ENSURE STREAMLINED ACCESS TO THE MARKETEFPIA supports a high standard of safety, efficacy and quality for DTx products while providing patientswith timely access. DTx are covered by EU regulation 2017/745 on medical devices and are considered
medical device software. Improvements to the existing regulatory pathway that would allow a flexible risk-based
approach to regulation would foster innovation and minimize risks to patients by not inhibiting the fast pace ofsoftware changes while maintaining high safety, efficacy and quality standards. In addition to the EU MDR,
DTx must comply with relevant EU and national-level regulations, including GDPR and some Member State
specific regulatory requirements related to security and privacy. Harmonization of regulatory requirements
across the Member States would facilitate development and commercialisation for developers, leading tofaster access for patients and HCPs. In fact, lack of harmonisation can increase uncertainty for DTx developers
and their investors, which can reduce investment in European health start-ups and leave companies without
the resources and financial power to bridge the “valley of death” between incubation and commercialisation.
To avoid regulatory delays and uncertainties, there is a need for clarity over the level of clinical evidence thatneeds to be provided (depending on the risk class) to obtain the CE mark. Finally, EU stakeholders and Member
States should develop capacity to ensure timely marketing approvals. This would ensure that patients areprovided with timely access while maintaining high standards.
Given the need for further clarity on how to interpret and implement regulatory requirements for DTx,
the Medical Device Coordination Group can play a role in clarifying the interpretation of regulatory
requirements across the EU to standardise regulatory approval, potentially including guidelines related tointerpretation of classification rules and evidence generation. Furthermore, with the emergence of EU
legislation on artificial intelligence – which is often used by DTx – there is a need for alignment between thesedifferent regulations.

VALUE ASSESSMENT REQUIREMENTS NEED TO BE TAILORED AND FIT-FOR-PURPOSEFOR DTX AND MORE PREDICTABLE AND CONSISTENT, AND INVOLVE A PORTFOLIOOF EVIDENCE THAT CAN INCLUDE REAL-WORLD EVIDENCE
There is a need for a holistic, risk-category based approach to value assessment to increase the predictability,
clarity, and consistency of evidence requirements across Member States. The value assessment of DTx shouldincorporate a broad portfolio of evidence that includes clinical data, consumer data, real-world evidence (RWE),
and accessibility data, leveraging the particular capabilities of DTx to generate patient-reported outcomes data.
These requirements should be clearly defined and transparent. The NICE Evidence Standards Framework provide
one benchmark. In particular, there is the potential for RWE to have a significant role in DTx value assessment,
given the data generated through the use of DTx. RWE should be accepted to support access but should not

15

be required for positive outcomes. Furthermore, a switch from indication-based HTA to a more patient-holistic
approach to value assessment is important, given that existing processes conduct evaluations only within specificindications. This is because indication-by-indication assessment does not support a patient-centric approachenabled by DTx whereby patients may be treated with a unique mix of modules depending on the individual’s
indications and comorbidities. Finally, as DTx have significant capabilities to collect patient reported outcome
measures (PROMs), the acceptance of PROMs in value assessment is also important.

MEMBER STATES AND THE EUROPEAN COMMISSION SHOULD CONSIDERSUPPORTING COLLABORATION BETWEEN COUNTRIES TO ENABLE HARMONISATIONOF EVIDENCE REQUIREMENTS
The European Commission should facilitate mutual recognition of evidence and collaboration between
countries to enable consistent and timely value assessment of DTx. Member States should explore
mutual recognition of clinical evidence by establishing a minimum set of requirements that are common acrossthe Member States. Furthermore, the Commission could support collaboration between Member States byfacilitating knowledge sharing and supporting the exchange of best practices and clinical evidence recognisedby national / sub-national HTA bodies and payers between the Member States. A positive first step towards
evidence harmonisation has been the establishment of the European Taskforce for Harmonised Evaluationof Digital Medical Devices, coordinated by EIT Health and co-funded by the EU. The work of the taskforce
focuses on three themes of harmonisation: taxonomy for different types of digital medical device (DMD); clinicalrequirements to assess DMDs; and socioeconomic evaluation of DMDs.47

 UROPEAN COMMISSION AND MEMBER STATE COLLABORATION WILL BE NEEDEDE
TO SUPPORT DATA SHARING AND BUILD INFRASTRUCTURE TO REALISE THE
POTENTIAL OF DATA GENERATED BY DTx
The Commission and Member States should support evidence generation. If successful, the European Health
Data Space (EHDS) will facilitate health data exchanges throughout the patient journey and strengthen
cooperation across Member States. To ensure this, appropriate data governance is fundamental to realise thepotential of health data in a trusted and secure way. EHDS will promote health data system interoperability
by further developing common interoperability standards. Interoperability will allow the exchange of healthdata across borders and enable citizens to have more continuous, well-informed healthcare regardless of theirpoint of interaction with healthcare system in Member States. The EU’s proposed Data Governance Act aims topromote trusted data sharing and may facilitate the sharing of health data across Member States.48

 EMBER STATES SHOULD CREATE CLEAR AND TRANSPARENT NATIONALM
PATHWAYS FOR DTx PRICING AND REIMBURSEMENTCountries should implement a separate national pathway for the reimbursement of standalone and companion
DTx, while for combination DTx, combined reimbursement of the DTx and pharmaceutical together ismore appropriate. New pathways should draw on lessons from existing pathways – particularly DiGA – but
the limitations of the DiGA process need to be considered, such as that only standalone DTx are eligible.
Combination DTx, by contrast, must be used with specific therapy and so combined reimbursement of the DTx
and pharmaceutical together is expected to be more appropriate. Reimbursement systems must recognise thata broad range of DTx exist, including digital solutions with multiple components that include a medical device
or associated services with the software.

16

PAYERS SHOULD PERMIT FLEXIBLE APPROACHES ALLOWING PROVISIONAL ACCESS
WHILE ADDITIONAL DATA IS GENERATED
In both Belgium and Germany, the specific DTx pathways permit provisional access to be on the market
and used by HCPs and patients for a limited period of time, and in France innovative products can receive
experimental coverage through Article 51 and Forfait Innovation. The real-world evidence this generates
can be used to support clinical and health economic assessments. This has the benefit of accelerating patient
access to innovative technologies while allowing payers to incorporate RWE into their finalised reimbursement
decisions. Implementing provisional access in the nearer term would be particularly beneficial in areas
with demonstrated unmet clinical or resource-related needs.

PAYERS SHOULD BE WILLING TO IMPLEMENT NOVEL PAYMENT MODELS TO
MANAGE EVIDENCE UNCERTAINTIESGiven that there is often uncertainty in the data package for DTx due to lack of comparators and the nature of
the technology, DTx value assessments should be adaptive and efficient enough to incorporate real-world datacollected before and after the value assessment. Novel payment models, such as outcome-based agreements
leveraging patient-reported outcome measures, could be attractive when payers are not convinced that clinicalevidence represents real-world patient care. Products that are subject to an outcomes-based agreement canrequest developers to collect additional data as part of the conditions for provisional access.

TO ENSURE THAT DTx ARE ADEQUATELY FUNDED, FUNDING NEEDS TO BE EXPLICIT
AND BUDGETED, AND SHOULD NOT HAVE A FINANCIAL BURDEN ON PATIENTS
DTx funding has been highlighted as a major challenge, with only a few countries making DTx available topatients. To ensure that DTx are adequately funded, funding needs to be explicit and budgeted. It should notpose a financial burden on patients and should be adequate and sustainable to allow healthcare providers
and patients to adopt DTx without fear of financial repercussions. Member States need to ensure sufficientbudget for DTx that deliver benefits to patients and healthcare systems, potentially by using funding models
which support value-based approaches. In addition to general healthcare budgets, the implementation of DTx
should be supported by budgets allocated to digital health.

INCREASING DTx UPTAKE WILL REQUIRE COLLABORATIVE EFFORTS BETWEENPOLICYMAKERS, HCPs, AND COMPANIES. TO DEVELOP TRUST IN DTx,STAKEHOLDERS MUST BE PREPARED TO WORK TOGETHER TO ENHANCE THE
EDUCATION AND EXPERIENCE OF HCPs AND PATIENTSEven if DTx are reimbursed and adequately funded, there is no guarantee of their uptake due to further
challenges in terms of HCP readiness to prescribe and patient willingness to use them. As a result, nationallevel policymakers should explore solutions to improving digital health literacy and information around DTx.
This could include investment in digital infrastructure, support for digital training, and ensuring that HCP timereceives adequate reimbursement that reflects the effort in monitoring, communication, patient education,and documentation. DTx developers should be ready to collaborate with other stakeholders to enable this,particularly to improve education and awareness among healthcare providers. This education, along withexperience, will be critical for building trust for all stakeholders with the emerging technology of DTx.

17

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